As a result, the sector is experiencing a gap between investments
in new medicines and the number of new drugs reaching the market, with return
on investment under increasing pressure.

“Even though the pharmaceutical industry depends heavily on the
discovery of innovative products, it is intensely conservative in the manner in
which it conducts clinical trials,” reads the book’s conclusion. “The dramatic
manner in which digital photography swept away a giant and long-established
film-based industry illustrates how those who stagnate may lose.”

Clinical
trials are a key part of evaluating the applicability and performance of
new drugs and/or therapeutic strategies, and they are paramount in obtaining
the approval of regulatory authorities, such as the Food and Drug
Administration (FDA) in the U.S. Typically, these authorities require clinical
trials to follow rigorous scientific standards designed to ensure unbiased
statistical estimates of the effectiveness of a new treatment on a target group
of patients, including safety from unwanted side effects.

Careful selection of patients and procedures for a clinical trial
and accurate statistical analysis of the resulting data are of critical
importance. Though the regulators are often well intentioned, strict regulatory
requirements can make the approval process for a new treatment very long and
costly. In fact, the delay and cost introduced by the approval process
constitute an important part of the overall time to market and development cost
of a new treatment.

The result is that only major pharmaceutical companies can afford to
bring new drugs to market and only after careful evaluation of costs against
potential benefits. This implies that some new drugs, which could save lives
and reduce suffering, might come too late, be priced beyond reach of most
patients or could never be introduced at all.

Therefore, it’s important to use modern information technology to
streamline the process of developing new drugs and treatments, of which
clinical trials are an important part.

“The enormous amounts of data generated in clinical trials, along
with trends towards globalization and increasing regulatory constraints, is
outstripping the ability of legacy data management platforms to manage the
competing needs of data sharing, patient privacy and data integrity,” noted
Jadhav, going on to discuss ways in which distributed ledgers could improve
patient recruitment, medical data sharing and privacy, data integrity, protocols
and the traceability of consent.

For example, blockchains could improve the patient recruitment
process by connecting patients with trials anonymously, as described in a
recent research
paper that shows how distributed ledgers can ensure traceability and
allow for securely automated clinical trials through smart contracts.
This paper also described how blockchain technology permits securely managed
patient consent data, time-stamped for each protocol revision in a clinical
trial.

Jadhav concluded that the potential applications of distributed
ledger technology to clinical research are wide-ranging and promising,
mentioning that IBM partnered with the FDA and the Centers for Disease Control
and Prevention (CDC) to pilot healthcare applications that involve both blockchain
technology and artificial intelligence, another emerging technology with great
potential to streamline healthcare processes.

Last November, IBM Watson Health, the IBM unit in charge of
healthcare applications of IBM’s Watson AI system, signed an
agreement with the CDC to explore the benefits of distributed ledger
technology in the health sector. In January, IBM Watson Health established
a partnership with the FDA to define a secure, efficient and scalable exchange
of health data using blockchain technology, with an initial focus on
oncology-related data. It seems this initiative is poised to approach a
restructuring of the clinical trial system as well.